PMA P890043
- Device
- FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P890043
- Supplement
- S034
- Product code
- MCX
- Decision date
- 2006-12-11
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIGENICS, SANTA TERESA, NEW MEXICO.
Current openFDA PMA Record
- Device
- FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P890043
- Supplement
- S039
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2006-12-11
- Decision code
- APPR
- Date received
- 2006-11-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIGENICS, SANTA TERESA, NEW MEXICO.